Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Palex Intl. SA · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
83 daysmedian FDA review time
154 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K905108 | CONTORNO(R), MODELS E AND ST | Palex Intl. SA | 1991-02-04 | 83 | 0 |
| K904586 | PALEX IRRIGATION SET | Palex Intl. SA | 1990-12-28 | 80 | 0 |
| K903224 | EPISENSOR | Palex Intl. SA | 1990-12-24 | 154 | 0 |
| K902642 | CONTORNO (TM) | Palex Intl. SA | 1990-08-07 | 54 | 0 |
| K901680 | BAUMAN RIGID LARYNGOSCOPE | Palex Intl. SA | 1990-07-12 | 91 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda